To help our biopharma and medtech customers with compliance and reporting, we share information, best practices, and easy access to documentation. Our BrightInsight Platform regularly undergoes independent verification of security, privacy, and compliance controls, achieving certifications against global standards to earn your trust. We’re constantly working to expand our coverage.
The CE mark appears on products in the EU to affirm that they comply with applicable EU regulations.
A regulation that governs the production and distribution of medical devices in Europe
Single regulatory audit of a medical device manufacturer to satisfy the relevant requirements of the regulatory authorities in the U.S., Canada, Japan, Brazil and Australia.
French hosting framework for Personal Health Information.
Industry agnostic certification framework for regulatory compliance and risk management.
Protecting personal information in compliance with stronger EU and UK data protection laws.
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